Regulation (EU) 2021/2282 on Health Technology Assessment (HTA) entered into force in January 2022 and will be phased in from January 2025 (information can be found here). The purpose of the Regulation is to increase the quality of OST in the European Union and to contribute to the improvement of patients' access to innovative technologies in the field of health care, such as medicinal products and medical devices paid for by public funds. It aims to harmonize the health technology assessment procedures of innovative drug therapies entering the European Union market in different countries, as well as to reduce the administrative burden for health technology developers.
The National Council on Prices and Reimbursement of Medicinal Products carries out a Health Technology Assessment of medicinal products, on the basis of Art. 259, paragraph 1, item 6 of the MEDICINAL PRODUCTS IN HUMAN MEDICINE ACT (SG, No. 102 of 2018, in force from 01.01.2019) and art. 1, item 8 and Chapter Six of the ORDINANCE ON THE TERMS, RULES AND PROCEDURE FOR REGULATION AND REGISTRATION OF PRICES FOR MEDICINAL PRODUCTS (SG, No. 26 of 2019, in force from 01.04.2019)
Health Technology Assessment summary reports: Pursuant to Art. 7, para. 6 of the ORDINANCE ON THE TERMS, RULES AND PROCEDURE FOR REGULATION AND REGISTRATION OF PRICES FOR MEDICINAL PRODUCTS (SG, No. 26 of 2019, in force from 01.04.2019). The Council publishes on its website the summary reports on the Health Technology Assessment only after written consent has been provided by the respective Marketing Authorization Holder of the evaluated medicinal product.